FDA Commissioner Scott Gottlieb has released a new statement denouncing the drug kratom. The statement says that the FDA has learned about new deaths that "involved" kratom use, additional adverse effects associated with its use have been found, and that Public Health Assessment via Structural Evaluation (PHASE) "3-D computer technology" has been used to analyze the chemical compounds in kratom:

Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

Nine leading scientists in substance addiction and safety wrote to White House Opioid Crisis Team Leader Kellyanne Conway and Acting DEA Administrator Robert W. Patterson requesting they disregard the FDA's latest disinformation campaign against kratom. The scientists warned that "four surveys indicate that kratom is presently serving as a lifeline away from strong, often dangerous opioids for many of the several million Americans who use kratom. A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain."

[...] David Herman, Chairman of the AKA, called upon FDA Commissioner Gottlieb to pull back the curtain on the "black box voodoo computer model" that was unveiled by the FDA to justify their continued 'War on Kratom,' this time claiming their computer model conclusively shows kratom is an opioid, and therefore had to be banned.

The nine respected scientists pointed out that "kratom provides a far more favorable safety profile for consumers compared to more dangerously addictive and potentially deadly classical opioid medications." They also pointed out that the FDA's solution – to file a new drug application for kratom – made no sense because "the average time and cost of new drug development is more than 10 years and 2.5 billion dollars."

In 2014, the FDA issued an import alert that allowed US Customs agents to detain kratom without a physical examination. "We have identified kratom as a botanical substance that could pose a risk to public health and have the potential for abuse," said Melinda Plaisier, the FDA's associate commissioner for regulatory affairs. According to the DEA, between February 2014 and July 2016, nearly 247,000 pounds of kratom were seized.

A bipartisan group of nine senators is calling on the Drug Enforcement Administration to delay its "unprecedented" decision to ban kratom, a plant that researchers say holds great potential for mitigating the effects of the opioid epidemic. [...] The Senate letter, spearheaded by Orrin G. Hatch (R-Utah) says: "Congress granted emergency scheduling authority to the DEA based on the need for law enforcement interdiction of new and previously unknown illegal synthetic street drugs that result in injuries and death. The use of this emergency authority for a natural substance is unprecedented, so it is important to determine whether the circumstances here necessitate a jump to Schedule I.

"Given the long reported history of Kratom use," the letter continues, "coupled with the public's sentiment that it is a safe alternative to prescription opioids, we believe using the regular review process would provide for a much-needed discussion among all stakeholders." [...] The DEA cites 600-plus poison-control center calls involving kratom between 2010 and 2015 in its justification for banning the plant, and notes that 15 deaths were linked to the use of the plant between 2014 and 2016. In an interview with The Washington Post, a DEA spokesman later clarified that all but one of those fatalities involved the use of other substances. Earlier this week 51 U.S. representatives similarly called on the DEA and the White House to reconsider or at least delay the ban, which was slated to go into effect as early as Friday. In an interview, DEA spokesman Russell Baer confirmed that the ban was not yet in place. "We have not yet determined a date when we will publish that final order" putting the ban into effect, he said.

There may be a public comment period before the ban takes effect, and the White House is now obligated to respond to the petition about kratom, which has reached over 140,000 signatures.

It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs.

There's clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.

Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.

New Jersey Gov. Chris Christie, head of the presidential commission on opioids, warned of the dangers of marijuana in a letter to President Donald Trump earlier this month about the panel's findings, saying the current push for marijuana legalization could further fuel the opioid epidemic.

"There is a lack of sophisticated outcome data on dose, potency, and abuse potential for marijuana. This mirrors the lack of data in the 1990s and early 2000s when opioid prescribing multiplied across health care settings and led to the current epidemic of abuse, misuse and addiction," Christie wrote in the letter, which was released with the commission's final report.

"The Commission urges that the same mistake is not made with the uninformed rush to put another drug legally on the market in the midst of an overdose epidemic."

[...] But some experts say the commission's fixation on marijuana was bizarre and troubling, lending credence to outdated views of marijuana as a gateway drug. And these experts want to nip such thinking in the bud.

"I was surprised to see negative language about marijuana in the opioid report," said Dr. Chinazo Cunningham, a professor of medicine at the Albert Einstein College of Medicine. "Research that examines pain and marijuana shows that marijuana use significantly reduces pain. In addition, the majority of studies examining marijuana and opioids show that marijuana use is associated with less opioid use and less opioid-related deaths."

An outbreak of 28 salmonella infections in 20 states has been linked to kratom products, the US Centers for Disease Control and Prevention said in a statement Tuesday. Though no deaths have been reported, 11 people have been hospitalized.

[...] California had the highest number of salmonella cases (three). North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania and Utah each reported two cases while Alabama, Arizona, Colorado, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, North Dakota, New York, South Carolina and Tennessee each reported a single case, the CDC found.

Kratom should not be consumed in any form, the CDC said, because the source of salmonella contamination has not been identified.

The U.S. Food and Drug Administration (FDA) has issued its first-ever mandatory recall for kratom-containing "food products", because the company selling them did not comply with the agency's request for a voluntary recall:

The Food and Drug Administration approved a powerful new opioid Friday, despite strong criticism and accusations that it bypassed its own advisory process to do it.

The new drug, Dsuvia, is a tablet that goes under the tongue. It is designed for use in the battlefield and in other emergency situations to treat intense, acute pain.

Known generically as sufentanil, it's a new formulation of a drug currently given intravenously. Critics say it will be incredibly easy for health workers to pocket and divert the drug to the illicit drug market and because it is so small and concentrated, it will likely kill people who overdose on it.

"This is a dangerous, reckless move," said Dr. Sidney Wolfe senior adviser of Public Citizen's Health Research Group. He questions whether there's need for yet another synthetic opioid when the U.S. is in the throes of an opioid overdose crisis.

Sufentanil is described as 5 to 10 times more potent than fentanyl and 500 times as potent as morphine. Carfentanil is 100 times more potent than fentanyl, but is only approved for the veterinary use of tranquilizing large animals. Sufentanil is the strongest opioid painkiller available for use in humans.

The Minority Leader of the Senate is making it official the day before 4/20: He's down with legal weed. In an exclusive interview with VICE News, Sen. Chuck Schumer (D-NY) confirmed he is putting his name on legislation that he said is aimed at "decriminalizing" marijuana at the federal level. For Schumer, this is a shift. While he has backed medical marijuana and the rights of states to experiment with legal sales of pot, what he is proposing is a seismic shift in federal drug policy.

"Ultimately, it's the right thing to do. Freedom. If smoking marijuana doesn't hurt anybody else, why shouldn't we allow people to do it and not make it criminal?" Schumer said.

Nuts, just nuts. Even if Kratom was an opiate (botanically it is not; it's more closely related to coffee) it would be the least prone to abuse and dangerous opiate known. I suspect that the reason it's disfavored by regulators is that it's an herbal product, not a refined pharmaceutical. It can't easily be patented in the form that it's usually consumed. Regulators would rather you take vikes or OC which their donors tell them are regulated, safe, tested, and reliable.

I am not a physician. I don't know if Kratom is good for opiate withdrawal or addiction maintenance. I can check the news and the literature with a simple web search and I can't find any news of people dying from it like they are from heroin, fentanyl, or other opiates. At the same time there seems to be a lot of anecdotal evidence that it helps many people either kick their addiction or replace it with a safer one. The government isn't saying we are banning this for the moment while we study it, they're just shutting the door indefinitely since the money barrier is so high.

This is unacceptable. You have a right to the pursuit of happiness, and if that means beating your addiction with Kratom I think you should pursue that.

You have a right to the pursuit of happiness in the same way a greyhound has a right to pursue the mechanical rabbit during a race. Your not allowed to catch happiness and the means of pursuit will be via high taxed means.

That's an interesting observation. Now, 'Creator' can be interpreted broadly - it could be the Big Bang. Anyway, a more compelling reason (IMO) to discount the 'right' is that it occurs in the Declaration and thus has no legal standing.

for every actionfor every action(Score: 3, Insightful) by Runaway1956 on Monday February 12 2018, @06:24AM
(4 children)

Fact 1: people are dying from opiate addictions.Fact 2: kratom has been mentioned in the same discussions as opioids.Conclusion: Opioids and kratom must be outlawed, and very strictly regulated.Course of Action: A new War on Drugs, this time including kratom.Results: More dead Americans - an easily replaceable resource, considering the number of illegal aliens clamoring for citizenship.

Re:for every action(Score: 2) by Freeman on Monday February 12 2018, @05:37PM

Considering what most citizens of 1st World countries think of as "poor", you would be right. There is a Huge population of people living in extreme poverty. The issue, is that most of them are a continent away. A majority of African countries have a large population of extremely poor people. I don't see see foreigners being desperate and eager for work as a good thing. It's an unfortunate reality. The poem on the Statue of Liberty is a wonderful ideal to strive towards and perhaps we should have a bit more welcoming policy towards immigrants. The problem I see, is that we've strayed too far away from the ideals that were put into motion in the founding of the United States of America. Though, there were definitely a few things that needed ironing out, such as Slavery and the Right to Vote.

There's a serious reason why herbal products are no longer used directly in today's medicine, and it has nothing to do with the fact that herbal medicines can't be patented: the amount of active ingredient in a particular herb varies greatly from plant to plant, and for many medicines the line between a therapeutic dose and a toxic one is a very fine one. Take digoxin, for instance, which is used to treat heart arrhythmias. You can get it in its natural form from the foxglove plant, but how much digoxin is available varies from one plant to the next. If you were unlucky one batch of foxglove you tried to use might have a dangerously high quantity of digoxin, and you'd kill a person if you gave a concoction like that to them.

Which is why this outright ban on kratom is even more perplexing to me. A pharmaceutical company that did research on the active ingredients in kratom could stand to make a very large amount of money if they could isolate the sources of its pharmacological action, and come up with proper drugs based on it that have reasonably well-understood effects. The "computational model" that the FDA seems to have done and used as a basis for banning it sounds like it is the equivalent of scribbling a few equations on the back of an envelope as far as pharmacological research goes. At the rate this is going it's going to be very costly for even a major drug company to do proper research of the kind needed to even establish the pharmacological usefulness of the compounds in kratom. Even though Scott Gottlieb is just about as big a pharma shill as they come [respectfulinsolence.com], I don't see how this ban benefits the pharma companies much either.

Why spend money investigating such a product? Tell me something, what is the status of the patents on oxycodone? It was discovered in 1916. Hydrocodone? Discovered in 1920. Fentanyl? Discovered in 1960. The patents for all of these opioid drugs expired long ago, meaning nobody has to pay anyone royalties to make them. The only reason why they're suddenly more profitable to the drug companies these days is largely because of an infamous letter in the New England Journal of Medicine in 1980 [bbc.com] alleging that addiction to opioids is "rare". Before this letter, doctors were much more reluctant to prescribe opioid painkillers out of concern for their addictive properties. The letter made these drugs much more profitable because it made doctors more willing to prescribe them, leading to the opioid crisis we have today. Now, if I were a big pharmaceutical company, I'd definitely want to do serious research into kratom. Given the kind of anecdotal evidence it carries, there's a reasonably good chance that there's something interesting in there, and the only way to find out is to actually do the research. If it pays off I could have a new, safer painkiller to compete with the dangerous opioids, and I would hold the patents on it. It would make my shareholders very rich indeed as the new drug would then be prescribed instead of the opioids. But if there are regulatory roadblocks to doing this kind of research, then it suddenly doesn't look like such a promising strategy. Look at how research into marijuana-derived compounds languished over the years thanks to the same sort of regulation that they're imposing on kratom today.

But then again, my thinking here is probably much more far-sighted than most of the MBAs that run Big Pharma these days. They'd be content to let R&D languish if doing so would make next quarter's numbers look slightly higher.

>> A pharmaceutical company that did research on the active ingredients in kratom could stand to make a very large amount of money if they could isolate the sources of its pharmacological action

The same pharmaceutical company should also look at https://en.wikipedia.org/wiki/Ibogaine [wikipedia.org] . It's a psychedelic herbal that anecdotally _permanently_ turns off the physical mechanisms of Opiod addiction in 90%+ of the people that try it. It was a non-trivial risk of death in herbal form, particularly if the patient has low K or Mg.

In fairness, this is an FDA ban on domestic sales of kratom, not a ban on its possession or import. A pharmaceutical company that wishes to isolate and market active chemicals here would in no way be precluded from doing so, especially since this ban doesn't in any way weigh in on the sale of the active chemical, merely the plant.

Notions of analogs and containers and all that are not applicable here, as this isn't a DEA schedule.

"There's a serious reason why herbal products are no longer used directly in today's medicine... the amount of active ingredient in a particular herb varies greatly from plant to plant... Take digoxin, for instance"

We aren't taking digoxin here; we're taking mitragynine and 7-hydroxymitragynine, and I have not seen any evidence that their respective alkaloid concentrations in the plant matter deviates in any unexpected way.

If you were unlucky one batch of foxglove you tried to use might have a dangerously high quantity of digoxin, and you'd kill a person

If you were unlucky and a batch of kratom had an unexpectedly high quantity of mitragynine or 7-hydroxymitragynine, you might give a person feelings of euphoria and/or discomfort for several hours.

Studies at places like Columbia University [acs.org] and University of Massachusetts Medical School [scientificamerican.com] indicate that unlike opioids (or "unlike other opioids" if you class these as such), mitragynine and 7-hydroxymitragynine don't have the respiratory depression effect that causes these overdose deaths that are behind the current "opioid crisis."

Of course, these compounds have an LD-50 *somewhere*, but the point is that their wide theraputic index [wikipedia.org] is nothing like the narrow tightrope walk that you're describing.

It makes sense that people who are unsettled by the thought of dosages that are not 100% consistent would prefer something like a standardized extract to just eating kratom leaves, but that scarcely seems to be the objection here.

Hmm, yeah, but I was smoking weed before it was recreational. Civil disobedience will start to be really effective when you have jury nullification. I believe that is what happened with the J20 prosecutions. The jury could see that it was about regulating unpopular speech and suppressing legal protests. They've let most of them go, and are continuing to double down on what is left. I predict that will also be jury nullification. Trump isn't popular, he didn't win the popular vote, and most people are on the side of the protesters.

Kratom, Big Pharma, and Law Enforcement are going to play out the same game. I wouldn't convict somebody of possessing Kratom, much less distributing it. I'm not particular interested in trying it either, but I'm also not particular interested in nasty veggies like asparagus. To each their own.

Government will always be trying to get power back, and with the astounding abuses of power that the DEA along with local enforcement have performed, they don't want to let go. When you have some LEO who is corrupt and willing to steal from the "bad guys", that's how you get them with sports cars, and all the trappings of wealth that the drug lord had.

The people that are trying to regulate Kratom are nothing more than state sponsored highwaymen.

Except that unless you convince the _entire_ jury to nullify, you risk a mistrial and a more hostile jury for the poor SOB whose life you’re toying with to take your personal agenda to court, which is why it is a weapon of last resort not to be deployed by fools, which is to say, almost everyone.

Re:No better than legislating the value of Pi to "(Score: 3, Informative) by requerdanos on Monday February 12 2018, @07:09PM

No better than legislating the value of Pi to "3"... Kratom's chemical properties are not under the jurisdiction of the FDA. Someone should let them know. This is insanity.

It's looking bad for kratom, but I don't think it's as bad as the headline makes it sound; it may be misleading.

Here's why (FTFS):

FDA Commissioner Scott Gottlieb said in a statement... "compounds in kratom make it so it isn’t just a plant — it’s an opioid."

This is from a strongly worded press release--a press release that doesn't say that "The FDA" is "Labeling" kratom as an opiod, just that in their opinion, that's what it is (despite evidence that it binds in a different way to the receptors, that it does not depress respiration as do opiods, etc.). And press releases are not the mechanism by which the FDA classifies drugs.

The regulatory labeling might not be far behind, but it hasn't happened yet.

Fifteen deaths in the United States between 2014 and 2016 were potentially kratom-related.[15] Examples of other substances found in autopsies along with kratom have included: propylhexedrine; acetaminophen, morphine, and promethazine; temazepam, diphenhydramine, and dextromethorphan. (In this last case, levels of mitragynine were higher than those of other drugs, and there was pulmonary edema and other signs of opioid toxicity, and kratom was declared the possible cause of death). In an additional case, there were high levels of mitragynine and signs of opioid toxicity on autopsy.

15 deaths in a three year span is 5/year (assuming it was the kratom and not anything else found along with it). Sounds like the ensuing war on Kratom will be extremely useful. Particularly when compared to the dangers of sleeping in your own bed:

855 people died when they accidentally and unintentionally strangled themselves with their blankets while sleeping.

In fact, unintentional falls are pretty dangerous: "Fall—In 2014, 33,018 persons died as the result of falls, 16.5% of all injury deaths (Table 18). The age-adjusted death rate for falls increased 3.4%, from 8.8 in 2013 to 9.1 in 2014. The overwhelming majority of fall-related deaths (96.8%) were unintentional."

Wow, I thought drowning in your own bathtub, with only an inch of water present, was the most pathetic way to die. But strangling with your own bedsheets is arguably worse.

Falls now, those are more respectable. Stairs are much more dangerous than people realize. I've slipped on stairs carpeted with medium length fiber because the nap was oriented upward and flipped downward as I stepped on it.

I came across one link I didn't use because it didn't seem a respectable source, but apparently, 450 people die in the US from falling out of bed every year. https://www.oddee.com/item_98002.aspx [oddee.com]

It's an accident that they die. It's not an accident that they get strangled. It's a sex thing. Let me mention a couple of guys, very famous. Michael Hutchence from INXS. David Carradine from Kill Bill. They died having VERY SPECIAL sex. Be careful, folks. Have a medical guy -- or lady -- around when you do those special things. Not a Fake one. The medical person, if you want, can be special too. Remember -- very important -- a Fake medical person can only do Fake medical. Or just do sex the regular way. I've had so much fun and made so many beautiful children that way!

David Herman, Chairman of the AKA, called upon FDA Commissioner Gottlieb to pull back the curtain on the "black box voodoo computer model" that was unveiled by the FDA to justify their continued 'War on Kratom,' this time claiming their computer model conclusively shows kratom is an opioid, and therefore had to be banned.

Apparently how the FDA came to the conclusion that kratom was an opioid is based on a black box computer model of some kind.

So, a software bug / feature? The only reason to have a "black box" is to protect something. In aviation, it's flight recorder data, which you want to be able to survive practically anything. When applied to software, it's called, making sure I can milk them for all they're worth. I.E. Money.

I remember reading in a different article that the concerns were mitragynine and 7-hydroxymitragynine, and that of special concern were "enhanced" kratom formulations with a higher proportion of the latter (some of which someone-who-isn't-me may or may not have a good supply of, and might use to help stay active in the face of chronic pain).

The FDA statement [fda.gov] here is light on details, but does mention mitragynine:

our scientists analyzed the chemical structure of these kratom compounds against the software to determine its likely biologic targets. The model predicted that 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors. This model, together with previously available experimental data, confirmed that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (“opioid agonists”).